Partnerships 2010: Where in the World is My Clinical Trial Manager? Managing Virtual Teams Across the Globe

Panelists: Lisa Feeney, Director, Clinical Operations, EXECUPHARM
Jessica Mills, Associate Director, Program Study Manager, PFIZER
Elspeth Carnan, PhD, Executive Director, Head Global Clinical Site Management, Global Development Operations, AMGEN
Diane Lewis, PhD, Director, COVANCE INC

This was another Q&A session that was made up of two members from the sponsor side and two members from the CRO side.

There was consensus that there was a shortage of qualified clinical trial managers (CTM) in emerging markets. To address the CTM issue in these markets, some of the panel members state that they outsource this function to locally available personnel. They also use functional service providers (FSP) in regions where they do not have a physical presence.

CTMs require years of experience to be fully proficient in their duties. This can take years to acquire the needed skills that are approrpiate to handle the assigned tasks. The key to this as explained by one panel member is to develop strong relationships between all team members including the local CRA and CTM. Some CRAs act as in-country/site managers due to their knowledge of existing social, cultural and regulatory matters.

Some comments regarding managing global trials included the use of FSPs for key operational activities as well as to grow internal personnel for these types of positions. Without question, the CRA needs to be a local given the communication issues involved in addition to those previously mentioned.

The makeup of the team is project dependent. Typically, a matrix environment is employed when forming a global team. This approach provides for clarity in assigned roles of the team members.

Problems or challenges faced when conducting studies in an emerging market include communication, time zone differences, lack of cultural understanding, connections issues associated with the internet of teleconferencing and difference in the understanding of terms used from one reegion to the other.